hydroxyzine pamoate

Generic: hydroxyzine pamoate

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine pamoate
Generic Name hydroxyzine pamoate
Labeler asclemed usa, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

hydroxyzine pamoate 100 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-922
Product ID 76420-922_2e63fa75-efcf-d9ee-e063-6394a90ab2d0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA088488
Listing Expiration 2026-12-31
Marketing Start 1984-07-01

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420922
Hyphenated Format 76420-922

Supplemental Identifiers

RxCUI
995232 995253 995278
UNII
M20215MUFR

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name hydroxyzine pamoate (source: ndc)
Generic Name hydroxyzine pamoate (source: ndc)
Application Number ANDA088488 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (76420-922-01)
  • 30 CAPSULE in 1 BOTTLE (76420-922-30)
  • 60 CAPSULE in 1 BOTTLE (76420-922-60)
  • 90 CAPSULE in 1 BOTTLE (76420-922-90)
source: ndc

Packages (4)

76420-922-01 100 CAPSULE in 1 BOTTLE (76420-922-01) 76420-922-30 30 CAPSULE in 1 BOTTLE (76420-922-30) 76420-922-60 60 CAPSULE in 1 BOTTLE (76420-922-60) 76420-922-90 90 CAPSULE in 1 BOTTLE (76420-922-90)

Ingredients (1)

hydroxyzine pamoate (100 mg/1)

Linked Drug Pages (1)

Hydroxyzine Pamoate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2e63fa75-efcf-d9ee-e063-6394a90ab2d0", "openfda": {"unii": ["M20215MUFR"], "rxcui": ["995232", "995253", "995278"], "spl_set_id": ["82187031-779e-47bc-943c-eb1a1ef30a7a"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (76420-922-01)", "package_ndc": "76420-922-01", "marketing_start_date": "20250218"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (76420-922-30)", "package_ndc": "76420-922-30", "marketing_start_date": "20250218"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (76420-922-60)", "package_ndc": "76420-922-60", "marketing_start_date": "20250218"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (76420-922-90)", "package_ndc": "76420-922-90", "marketing_start_date": "20250218"}], "brand_name": "Hydroxyzine Pamoate", "product_id": "76420-922_2e63fa75-efcf-d9ee-e063-6394a90ab2d0", "dosage_form": "CAPSULE", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "76420-922", "generic_name": "Hydroxyzine Pamoate", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxyzine Pamoate", "active_ingredients": [{"name": "HYDROXYZINE PAMOATE", "strength": "100 mg/1"}], "application_number": "ANDA088488", "marketing_category": "ANDA", "marketing_start_date": "19840701", "listing_expiration_date": "20261231"}